Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese Women

Obesity Clinical Trial

Official title:

Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01255228
• Other study ID #: 99055
• Status: Active, not recruiting
• Phase: N/A
• First received: November 18, 2010
• Last updated: December 5, 2010
• Start date: May 2010
• Est. completion date: April 2011

Study information

• Verified date: December 2010
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Excessive body weight and obesity have reached epidemic proportions over the last few decades, which may cause many chronic diseases. Maintaining a healthy life style could decrease the risk for obesity, metabolic syndrome and cardiovascular disease. The study aimed to evaluate long-term low glycemic index (GI) diet intervention on lipid profile, body composition and the mechanism of obese women. The pilot study will recruit twenty healthy subjects, and served test food to determine low GI food. In the experiment period, twenty women age from 20-50 years will be recruited. To be included in the study, subjects should have a BMI above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline > 80 cm). Before dietary intervention, participants will receive food choice table and dietary questionnaires to record their dietary intake.

The study will be a randomized, crossover, controlled clinical trails. The experiment period have six weeks, each participants will provide low GI diet (lunch and dinner). On the 0, 3, 6 week, subjects will measurement their body composition (body weight, body mass, waist and hip circumferences) and collect fasting blood samples to analysis the lipid profile, free fatty acid, blood sugar, insulin, adiponectin, leptin and fatty acid synthesis enzymes. Statistical analysis will be performed by paired t-test. The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• BMI above 24 kg/m2, or the either one ( fat mass ? 30% or waistline > 80 cm )

Exclusion Criteria:

• Cardiovascular disease

• type 2 diabetes mellitus or impaired glucose tolerance

• serious liver or renal disease, gastro-intestinal disease

• proceed serious diet control for formerly three months

• take any supplemental food products or medications known to influence lipid or carbohydrate metabolism

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Low glycemic index diet
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effect of body composition ( body weight,body mass,waist and hip circumferences )		6 week	No